CHENGDU, China, and
EMERYVILLE, Calif., June 30, 2021 /PRNewswire/ -- Clover
Biopharmaceuticals (Clover), a global clinical-stage biotechnology
company developing novel vaccines and biologic therapeutic
candidates to address the world's most life-threatening diseases
and public health threats, and Dynavax Technologies Corporation
(Dynavax, Nasdaq: DVAX), a biopharmaceutical company focused on
developing and commercializing novel vaccines, today
announced the execution of a commercial supply agreement of
Dynavax's CpG 1018™ advanced adjuvant, for
use in Clover's protein-based COVID-19 vaccine candidate, SCB-2019
(CpG 1018/Alum).
The commercial supply agreement extends to the end of 2022.The
agreement includes doses for delivery in 2021, which were
manufactured under the previously announced funding agreement
between Coalition for Epidemic Preparedness Innovations (CEPI)
and Dynavax.
Clover separately announced today an advanced purchase agreement
with Gavi, the Vaccine Alliance, for supplying up to 414 million
doses of SCB-2019 (CpG 1018/Alum) through 2022 for the COVAX
Facility. The COVAX Facility is a global risk-sharing mechanism for
pooled procurement and equitable distribution of COVID-19 vaccines,
regardless of income level. Pending conditional regulatory
approvals, Clover expects to commence product launch of SCB-2019
(CpG 1018/Alum) by the end of 2021, supplying the COVAX Facility
and countries directly via government procurement and/or bilateral
supply agreements.
"Throughout the development of our COVID-19 vaccine candidate,
Dynavax has been an invaluable partner with a shared goal of
maximizing our collective impacts in fighting the unprecedented
COVID-19 pandemic. We look forward to the continued partnership as
we accelerate large-scale production of SCB-2019 (CpG 1018/Alum)
for potential commercial supply to communities in need around the
globe," stated Joshua Liang, Chief
Executive Officer of Clover Biopharmaceuticals.
Ryan Spencer, Chief Executive
Officer of Dynavax commented, "Dynavax is excited for the
opportunity to expand our partnership with Clover into an important
commercial supply agreement to provide significant amounts of CpG
1018 for combatting the ongoing pandemic. We are proud to support
the ongoing development and the potential near-term
commercialization of SCB-2019 (CpG 1018/Alum)."
About SCB-2019 (CpG 1018/Alum)
SCB-2019 (CpG
1018/Alum), Clover's COVID-19 vaccine candidate, is anticipated to
be one of the first commercialized protein-based COVID-19 vaccines
globally through the COVAX Facility. Employing the Trimer-Tag©
technology platform, Clover developed the SCB-2019 antigen, a
stabilized trimeric form of the S-protein (S-Trimer) based on the
original strain of the SARS-CoV-2 virus. Clover's COVID-19 vaccine
candidate is the combination of SCB-2019 and two adjuvants,
Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide
(alum).
Clover is currently advancing SPECTRA, a global pivotal Phase
2/3 clinical trial evaluating the efficacy, safety, and
immunogenicity of SCB-2019 (CpG 1018/Alum), and expects interim
data for vaccine efficacy around the middle of 2021. Pending
positive interim data, Clover plans to submit conditional
regulatory approval applications to the EMA, the NMPA and the WHO
in the second half of 2021, and plans to commence product launch by
the end of 2021.
About Clover Biopharmaceuticals
We are a global
clinical-stage biotechnology company committed to developing
novel vaccines and biologic therapeutic candidates to address
the world's most life-threatening diseases and public health
threats. The Trimer-Tag© technology is a product development
platform for the creation of novel vaccines and
biologic therapies. We have leveraged our Trimer-Tag©
technology platform to become a COVID-19 vaccine developer and
potentially one of the first companies to commercialize a
protein-based COVID-19 vaccine globally through the COVAX
Facility. For more information, please visit our
website: www.cloverbiopharma.com and follow the company
on LinkedIn.
Clover Forward-looking Statements
This press release
contains certain forward-looking statements and information
relating to us and our subsidiaries that are based on the beliefs
of our management as well as assumptions made by and information
currently available to our management. When used in this
[document], the words "aim," "anticipate," "believe," "could,"
"estimate," "expect," "going forward," "intend," "may," "might,"
"ought to," "plan," "potential," "predict," "project," "seek,"
"should," "will," "would" and the negative of these words and other
similar expressions, as they relate to us or our management, are
intended to identify forward-looking statements.
Forward-looking statements are based on our current expectations
and assumptions regarding our business, the economy and other
future conditions. We give no assurance that these expectations and
assumptions will prove to have been correct. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict. Our results may differ materially from
those contemplated by the forward-looking statements. They are
neither statements of historical fact nor guarantees or assurances
of future performance. We caution you therefore against placing
undue reliance on any of these forward-looking statements. Any
forward-looking statement made by us in this document speaks only
as of the date on which it is made. Factors or events that could
cause our actual results to differ may emerge from time to time,
and it is not possible for us to predict all of them. Subject to
the requirements of applicable laws, rules and regulations, we
undertake no obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
All forward-looking statements contained in this document are
qualified by reference to this cautionary statement.
About CpG 1018
CpG 1018 is the adjuvant used in
HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted], an
adult hepatitis B vaccine approved by the U.S. Food and Drug
Administration (FDA) and the European Commission. Dynavax developed
CpG 1018 to provide an increased vaccine immune response, which has
been demonstrated in HEPLISAV-B. CpG 1018 provides a well-developed
technology and a significant safety database, potentially
accelerating the development and large-scale manufacturing of a
COVID-19 vaccine.
About Dynavax
Dynavax is a commercial stage
biopharmaceutical company developing and commercializing novel
vaccines. The Company's first commercial product, HEPLISAV-B®
[Hepatitis B Vaccine (Recombinant), Adjuvanted], is approved in the
U.S. and Europe for prevention of
infection caused by all known subtypes of hepatitis B virus in
adults age 18 years and older. Dynavax is also advancing CpG 1018
as a premier vaccine adjuvant through research collaborations and
partnerships. Current collaborations are focused on adjuvanted
vaccines for COVID-19, pertussis and universal influenza. For more
information, visit www.dynavax.com and follow the company on
LinkedIn.
Dynavax Forward-Looking Statements
This press release
contains "forward-looking" statements, including statements
regarding the potential to develop a COVID-19 vaccine containing
CpG 1018, the timing and amount of potential sales to Clover and
the timing of regulatory approvals. Actual results may differ
materially from those set forth in this press release due to the
risks and uncertainties inherent in vaccine research and
development, including the timing of initiating clinical trials and
completing development, whether CpG 1018 plus aluminum combined
with Clover's protein subunit vaccine will prove to be beneficial
in clinical trials, whether and when the vaccine will be approved
for use, whether CEPI will continue to fund the Clover program
through development and licensure, whether or how much Gavi or
other commercial customers purchase from Clover, and whether
sufficient quantities of CpG 1018 will be able to be manufactured,
as well as other risks detailed in the "Risk Factors" section of
our Annual Report on Form 10-K for the fiscal year ended
December 31, 2020, as well as
discussions of potential risks, uncertainties and other important
factors in our other filings with the U.S. Securities and Exchange
Commission. We undertake no obligation to revise or update
information herein to reflect events or circumstances in the
future, even if new information becomes available. Information on
Dynavax's website at www.dynavax.com is not incorporated by
reference in our current periodic reports with the SEC.
Clover Biopharmaceuticals:
Cindy Min
Vice President, Public Affairs
media@cloverbiopharma.com
Naomi Eichenbaum
Vice President, Investor Relations
investors@cloverbiopharma.com
Dynavax Contacts:
Nicole
Arndt
Senior Manager Investor Relations
narndt@dynavax.com
510-665-7264
Derek Cole
President,
Investor Relations Advisory Solutions
derek.cole@IRadvisory.com
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SOURCE Dynavax Technologies